Syndesmosis construct

ABSTRACT

A knotless button includes a body defining a proximal portion and a distal portion. The body further defines an internal cavity and a first loop opening extending from the internal cavity to an outer surface of the body. A locking insert is slideably positioned within the internal cavity. The locking insert defines a second loop opening extending from a first side of the locking insert to a second side of the locking insert. The locking insert is slideably moveable from a first position to a second position within the internal cavity. A flexible strand defines a first adjustable loop extending through the first loop opening and the second loop opening. The locking insert is slideably moveable from a first position configured to allow adjustment of the first adjustable loop to a second position configured to lock the first adjustable loop.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a national phase entry under 35 U.S.C. 371 ofinternational patent application No. PCT/US17/67330, filed Dec. 19,2017, which claims benefit to U.S. Provisional Application Ser. No.62/437,390, filed Dec. 21, 2016, entitled “SYNDESMOSIS CONSTRUCT,” theentireties of which are incorporated herein by reference.

BACKGROUND

Various injuries include separation of soft tissue from one or morebones and/or separation of bones from normally anatomical correctpositioning. Maintaining the bones in the correct anatomical positionsduring healing is important to provide proper soft tissue reattachmentand proper bone healing. For example, during syndesmosis repair, a firstbone and a second bone must be maintained in a fixed position to allowthe connective tissue to refuse.

Current suture systems include one or more knots for maintaining suturesin a fixed position. Knots formed on the sutures can cause irritationduring healing and may be subject to tearing due to friction or otherforces applied to the knot. Current systems further require surgeons toform knots during surgery. Such systems are prone to failure andincrease time of surgery.

SUMMARY

In various embodiments, a knotless button is disclosed. The knotlessbutton includes a body defining a proximal portion and a distal portion.The body further defines an internal cavity and a first loop openingextending from the internal cavity to an outer surface of the body. Alocking insert is slideably positioned within the internal cavity. Thelocking insert defines a second loop opening extending from a first sideof the locking insert to a second side of the locking insert. Thelocking insert is slideably moveable from a first position to a secondposition within the internal cavity. A flexible strand defines a firstadjustable loop extending through the first loop opening and the secondloop opening. The locking insert is slideably moveable from a firstposition configured to allow adjustment of the first adjustable loop toa second position configured to lock the first adjustable loop.

In various embodiments, a knotless button is disclosed. The knotlessbutton includes a body defining a proximal portion and a distal portion.The body defines an internal cavity including at least one first lockingfeature. A locking insert is slideably receivable within the internalcavity. The locking insert defines a first loop opening extending from afirst side to a second side. The locking insert is slideably moveablefrom a first position to a second position within the internal cavity.The locking insert is configured to receive a flexible strand defining afirst adjustable loop through the first loop opening. The locking insertincludes at least one second locking feature. The at least one firstlocking feature and the at least one second locking feature areconfigured to selectively couple to prevent movement of the lockinginsert with respect to the body.

In various embodiments, a method of coupling a first bone and a secondbone is disclosed. The method includes the step of forming a bone tunnelthrough a first bone and a second bone. A knotless button is inserted atleast partially through the bone tunnel. The knotless button includes abody defining a proximal portion and a distal portion. The distalportion defining an internal cavity and a first loop opening. A lockinginsert is slideably positioned within the internal cavity and defining asecond loop opening extending from a first side to a second side. Aflexible strand defines a first adjustable loop extending through thefirst loop opening and the second loop opening. The first adjustableloop is coupled to the second bone. The first adjustable loop isadjusted to position the first bone and the second bone. Adjusting thefirst adjustable loop to slideably transition the locking insert from afirst position in which the first adjustable loop is adjustable to asecond position in which the first adjustable loop is locked.

BRIEF DESCRIPTION OF THE FIGURES

The features and advantages of the present invention will be more fullydisclosed in, or rendered obvious by the following detailed descriptionof the preferred embodiments, which are to be considered together withthe accompanying drawings wherein like numbers refer to like parts andfurther wherein:

FIG. 1 illustrates a surgical site including a first bone and a secondbone coupled by an anchoring construct, in accordance with someembodiments.

FIG. 2A illustrates a knotless button having a locking insert in a firstposition, in accordance with some embodiments.

FIG. 2B is a cross-section of the knotless button of FIG. 2A, inaccordance with some embodiments.

FIG. 2C is a side-view of the knotless button of FIG. 2A, in accordancewith some embodiments.

FIG. 3A illustrates the knotless button of FIGS. 2A-2C having a lockinginsert in a second position, in accordance with some embodiments.

FIG. 3B is a cross-section of the knotless button of FIG. 3A, inaccordance with some embodiments.

FIG. 3C is a side-view of the knotless button of FIG. 3A, in accordancewith some embodiments.

FIG. 4 illustrates an anchoring construct including the knotless buttonof FIGS. 2A-3C having a first adjustable loop coupled thereto, inaccordance with some embodiments.

FIG. 5 illustrates an anchoring construct including the knotless buttonof FIGS. 2A-3C having a first adjustable loop and a second adjustableloop coupled thereto, in accordance with some embodiments.

FIG. 6A illustrates a front view of a knotless button configured toreceive at least one adjustable loop therethrough, in accordance withsome embodiments.

FIG. 6B illustrates a top view of the knotless button of FIG. 6A, inaccordance with some embodiments.

FIG. 6C illustrates a side view of the knotless button of FIG. 6A, inaccordance with some embodiments.

FIG. 6D illustrates a bottom view of the knotless button of FIG. 6A, inaccordance with some embodiments.

FIG. 6E illustrates a cross-sectional view of the knotless button ofFIG. 6A, in accordance with some embodiments.

FIG. 7A illustrates a knotless button configured to receive at least oneadjustable loop therethrough, in accordance with some embodiments.

FIG. 7B illustrates a top view of the knotless button of FIG. 7A, inaccordance with some embodiments.

FIG. 7C illustrates a side view of the knotless button of FIG. 7A, inaccordance with some embodiments.

FIG. 7D illustrates a bottom view of the knotless button of FIG. 7A, inaccordance with some embodiments.

FIG. 8 illustrates a self-tightening insert configured to be receivedwithin a knotless button, in accordance with some embodiments.

FIG. 9 illustrates an anchoring construct coupled to a needle andconfigured for insertion through a bone tunnel, in accordance with someembodiments.

FIG. 10 illustrates the anchoring construct of FIG. 9 partially coupledto a first bone and a second bone through a bone plate, in accordancewith some embodiments.

FIGS. 11A-11C illustrate knotless buttons at least partially insertedthrough one or more button holes in a bone plate, in accordance withsome embodiments.

FIG. 12 illustrates a flat button configured to couple to an adjustableloop, in accordance with some embodiments.

FIG. 13 illustrates a method for syndesmosis repair using an anchoringconstruct, in accordance with some embodiments.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. In the description, relativeterms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,”“below,” “up,” “down,” “top” and “bottom” as well as derivative thereof(e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing under discussion. These relative terms are for convenienceof description and do not require that the apparatus be constructed oroperated in a particular orientation. Terms concerning attachments,coupling and the like, such as “connected,” refer to a relationshipwherein structures are secured or attached to one another eitherdirectly or indirectly through intervening structures, as well as bothmovable or rigid attachments or relationships, unless expresslydescribed otherwise.

In various embodiments, an anchoring construct including a flexiblestrand defining at least one adjustable loop is disclosed. Theadjustable loop is coupled to a knotless button at a first end. Theknotless button includes a body defining an internal cavity configuredto receive a locking insert therein. The body of the knotless button andthe locking insert each define a loop channel. The adjustable loopextends through the loop channel and is further looped beneath a distalend of the locking insert. The locking insert is configured totransition from a first position in which the adjustable loop can beadjusted and a second position in which the adjustable loop is locked.In some embodiments, a second end of the adjustable loop is coupled to aflat button.

FIG. 1 illustrates a surgical site 100 including a first bone 102 and asecond bone 104 coupled by an anchoring construct 2. The anchoringconstruct 2 is configured to limit the movement and/or position of thefirst bone 102 with respect to the second bone 104. The anchoringconstruct 2 includes a flexible strand 4 defining at least one loop 6extending from a proximal end 8 to a distal end 10. The flexible strand4 can include any suitable material, such as, for example, one or moresutures, threads, ribbons, and/or other suitable flexible material. Insome embodiments, an adjustment portion 12 of the flexible strand 4extends proximally from the at least one loop 6. The adjustment portion12 is configured to provide adjustment (e.g.,lengthening/shortening/tightening/loosening) of the at least oneflexible loop 6.

In some embodiments, the proximal end 8 of the at least one adjustableloop 6 is coupled to a knotless button 14. The knotless button 14includes one or more openings for receiving the at least one loop 6, asdiscussed in more detail below. For example, as discussed in more detailwith respect to FIGS. 4A-5E, in some embodiments, the knotless button 14includes a body defining a first loop opening and a second loop openingconfigured to receive the at least one flexible loop 6 therethrough. Theknotless button 14 anchors the proximal end 8 of the at least oneflexible loop 6 to a first side 102 a (such as, for example, a lateralside) of the first bone 102. In some embodiments, a locking insert ispositioned within the inner cavity (see FIG. 2) and is configured tomaintain the adjustable loop 6 at a preselected length.

In some embodiments, a distal end 10 of the at least one flexible loop 6is coupled to a flat button 16. The flat button 16 includes one or moreopenings configured to receive a portion of a flexible loop 6therethrough. The at least one flexible loop 6 is looped around and/orthrough a portion of the flat button 16. The flat button 16 anchors thedistal end 10 of the at least one flexible loop 6 to a medial side 104 bof the second bone 104.

In some embodiments, the knotless button 14 is coupled to a bone plate20. The bone plate 20 can be coupled to the first side 102 a of thefirst bone 102. The bone plate 20 includes a body 22 extending between afirst (or bone-contact) surface 24 and an opposing second (or outer)surface 26 (see FIGS. 11A-11C). The body 22 has a predeterminedthickness. In some embodiments, the body 22 defines one or more anchorholes and/or one or more fastener holes. For example, in the illustratedembodiment, the body 22 defines at least one button hole 28 sized andconfigured to receive a knotless button (e.g., the knotless button 14)at least partially therethrough (see FIGS. 11A-11C). The button hole 28can define a countersink (see FIGS. 11A-11C) configured to receive aproximal portion of the knotless button 14. In some embodiments, thebone plate 20 further defines one or more fastener holes 29 configuredto receive a fastener therethrough to couple the bone plate 20 to afirst bone 102 (see FIG. 10).

In some embodiments, the adjustable loop 6 extends from the first side102 a of the first bone 102 to a second side 104 b of the second bone104 through a bone tunnel 106 defined in the first and second bones 102,104. The bone tunnel 106 includes a first portion 106 a extending fromthe first side 102 a to a second side 102 b of the first bone 102 and asecond portion 106 b extending from a first side 104 a to the secondside 104 b of the second bone 104. The bone tunnel 106 can be formedusing any suitable surgical device, such as, for example, a drill, ak-wire, an impactor, a needle, and/or any other suitable device.

In some embodiments, the bone tunnel 106 has a diameter sufficient toallow the flat button 16 to pass through the bone tunnel 106 in a firstconfiguration. The flat button 16 may include an oblong (or elliptical)shape having a first diameter 96 a greater than a second diameter 96 b(see FIG. 12). When the oblong flat button 16 is positioned at a firstorientation (such as with the long axis 96 a of the elliptical shapeparallel to an axis 107 of the bone tunnel 106), the flat button 16 isable to pass through the bone tunnel 106. When the flat button 16 ispositioned at a second orientation (e.g., with the long axis 96 a of theelliptical shape substantially perpendicular to the axis 107 of the bonetunnel 106), the flat button 16 is not able to pass through the bonetunnel 106. In other embodiments, the bone tunnel 106 has a diametersufficient to allow passage of an adjustable loop 6 and one or morepassage elements, such as a needle but less than either of the diameters96 a, 96 b of the flat button 16. The flat button 16 can be coupled toone or more of the adjustable loops 6 after insertion of the adjustableloop 6 through the bone tunnel 106. In some embodiments, the adjustableloop 6 is passed through the bone tunnel 106 using one or more elements,such as, for example, a needle 86 (see FIG. 10).

The adjustable loop 6 is adjusted (e.g., shortened/lengthened) toposition the first bone 102 and the second bone 104 in a predeterminedspaced relationship. In some embodiments, the adjustment portion 12 ofthe flexible strand 4 extends through an opening formed in a proximalend of the knotless button 14. The adjustment portion 12 can bemanipulated (e.g., pulled) to shorten/tighten the adjustable loop 6 toposition the first bone 102 and the second bone 104. When the first bone102 and the second bone 104 are in the predetermined spaced arrangement,the locking insert can be locked to prevent movement of the adjustableloop 6. For example, in some embodiments, the locking insert locks theadjustable loop 6 at a selected length to limit the movement of thefirst and second bones 102, 104 to a predetermined range of motion.

FIGS. 2A-2C illustrate a knotless button 14 a, in accordance with someembodiments. The knotless button 14 a is similar to the knotless button14 discussed above, and similar description is not repeated herein. Theknotless button 14 a includes a body 30 extending between a proximal end32 a and a distal end 32 b. The body 30 can have any suitable shape,such as, for example, a cylindrical shape, a rectangular shape, apyramidal shape, and/or any other suitable shape. In some embodiments,the body 30 has a first diameter 37 a. Further, the body 30 includes aproximal cap 34 located at a proximal end 32 a of the body 30. In someembodiments, the proximal cap 34 has a second diameter 37 b that isgreater than the first diameter 37 a. It should be noted that theproximal cap 34 may be integral with the body 30 (e.g., a monolithicconstruct). In other embodiments, the proximal cap 34 may be provided asa separate component or piece, connectively attached or received by thebody 30.

In some embodiments, the body 30 defines a first loop opening 36 a and asecond loop opening 36 b. The loop openings 36 a, 36 b are sized andconfigured to receive a portion of the adjustable loop 6 therethrough.The adjustable loop 6 extends distally from at least one of the loopopenings 36 a, 36 b. In some embodiments, the loop openings 36 a, 36 bdefine a loop channel 36 extending through the body 30 of the knotlessbutton 14 a.

The body 30 defines an internal cavity 48 sized and configured toreceive a locking insert 60 therein. In some embodiments, the internalcavity 48, extends along a length of the body 30, from the proximal end32 a to the distal end 32 b. The proximal end 32 a and/or the distal end32 b can define a closed end or an open end. For example, in someembodiments, a first opening 42 can be defined by and extend through theproximal cap 34 to the internal cavity 48 such that the internal cavity48 defines a channel extending from the first opening 42 to the distalend of the body 32 b. The locking insert 60 can be slideably receivedwithin the internal cavity 48 by inserting the locking insert 60 throughthe first opening 42. In some embodiments, where the body comprises aseparate proximal cap 34, the locking insert 60 can be inserted into theinternal cavity 48 prior to coupling the proximal cap 34 to the body 30.The first opening 42 may be a longitudinal opening configured to match across-sectional area of the internal cavity 48 and/or a cross-sectionalarea of the locking insert 60.

In some embodiments, the locking insert 60 is slideably moveable withinthe internal cavity 48 along a vertical axis of the body 30 from a first(proximal) position defining a strand receiving space 52, as illustratedin FIGS. 2A-2C, to a second (distal) position in which the lockinginsert 60 is positioned substantially within the strand receiving space52, as illustrated in FIGS. 3A-3C. In some embodiments, the lockinginsert 60 includes one or more first locking features 68 a, 68 b sizedand configured to couple to and/or interact with second locking features38 a, 38 b defined by the body 30. The first locking features 68 a, 68 bare configured to retain the locking insert 60 in the second position.In some embodiments, the first locking features 68 a, 68 b (such as tabsextending laterally from the locking insert 60) interact with a stopsurface 80 when the locking insert 60 is positioned within the internalcavity 48. The stop surface 80 can be defined by the proximal cap 34and/or the proximal end 32 a of the body 30. The first locking features68 a, 68 b interface with the stop surface 80 which prevents the lockinginsert 60 from being removed proximally from the internal cavity 48. Insome embodiments, the first locking features 68 a, 68 b, define a flatproximal surface configured to interface with stop surface 80. In otherembodiments, the first and second locking features can comprise anysuitable cooperating locking features.

In some embodiments, the locking insert 60 is configured to flex orotherwise deform during insertion into and/or removal from the internalcavity 48. For example, in the illustrated embodiment, a slot 66 dividesa proximal end 62 a into a first prong 64 a and a second prong 64 b thatcan be flexed towards a center line of the locking insert 60 duringinsertion and/or removal of the locking insert 60.

In some embodiments, the body 30 comprises a material which enables thelocking insert 60 to transition from the second, closed position to thefirst, open or unlocked position. For example, the body 30 of theknotless button 14 a can be temporarily deformable to release thelocking insert 60 and/or deform the first opening 42 such that thelocking insert 60 can be transitioned from the second position to thefirst position. The body 30 may be formed from a semi-resilient materialand/or semi-deformable material. Deformation of the body 30 (e.g.,compressing or squeezing) releases the first locking features 68 a, 68 bfrom the second locking features 38 a, 38 b, allowing the locking insert60 to transition from the second position to the first position. In someembodiments, deformation of the body 30 further allows the lockinginsert 60 to be removed from the internal cavity 48. Althoughembodiments are discussed herein including a deformable body 30, it willbe appreciated that the locking insert 60 can transition from the secondposition to the first position using any suitable system.

In some embodiments, the locking insert 60 defines a loop opening 70extending through the locking insert 60. The loop opening 70 is sizedand configured to receive a portion of the adjustable loop 6therethrough. When the locking insert 60 is at least partially insertedinto the internal cavity 48 (e.g., is in the first position), the loopopening 70 is at least partially aligned with the loop openings 36 a, 36b defined by the body 30. When the loop opening 70 is aligned with theloop openings 36 a, 36 b, a portion of a flexible strand, such asflexible strand 4 illustrated in FIG. 1, is passed through the firstopening 36 a, the loop opening 70, and the second opening 36 b such thatan adjustable loop is partially disposed within the loop channel 36 asdefined by the loop openings 36 a, 36 b, 70.

In some embodiments, the locking insert 60 has a first length extendingfrom a proximal end 62 a to a distal end 62 b. The first length of thelocking insert 60 is less than a length of the internal cavity 48extending from a proximal end 32 a to a distal end 32 b. When thelocking insert 60 is positioned in a first position, a strand receivingspace 52 is defined between a distal end 62 b of the locking insert 60and a distal end 32 b of the internal cavity 48. The strand receivingspace 52 is configured to receive a portion of an adjustable looptherein, as discussed in more detail below with respect to FIGS. 4-5.

In some embodiments, the locking insert 60 is configured toautomatically transition from a first position (e.g., proximal-mostposition) to a second position (e.g., distal-most position) when anadjustable loop is shortened (e.g., tightened) to a predeterminedlength. For example, as shown in FIG. 1, the adjustable loop 6 extendsfrom the knotless button 14 coupled to a first side 102 a of a firstbone to a flat button 16 coupled to a second side 104 b of a second bone104. When the adjustable loop 6 is shortened, the position of the firstand second bones 102, 104 is adjusted by a force applied by theadjustable loop 6. When the force applied to the first and second bones102, 104 by the adjustable loop 6 reaches a predetermined value, theadjustable loop 6 causes the locking insert 60 to transition from thefirst position to the second position and lock the adjustable loop 6 ata predetermined length.

In some embodiments, the locking insert 60 can be transitioned from thefirst position to the second position manually, such as, for example,using a finger, a tool, and/or any other suitable instrument. Forexample, when the adjustable loop 6 is shortened to a preselectedlength, a force is applied to the proximal end 62 a of the lockinginsert 60 to transition the locking insert 60 to the second position.The transition force causes the first locking features 68 a, 68 b tointeract with the second locking features 38 a, 38 b to lock theadjustable loop 6 at the preselected length.

FIGS. 2A-2C illustrate a knotless button 14 a having the locking insert60 positioned in the first position, in accordance with someembodiments. The first locking features 68 a, 68 b of the knotlessbutton 14 b includes one or more tabs extending laterally from thelocking insert 60 and the second locking features 38 a, 38 b includeslots defined by the body 30. The first locking features 68 a, 68 b areconfigured to be received within and retained by the second lockingfeatures 38 a, 38 b. In some embodiments, the first locking features 68a, 68 b are configured to transition from a first position to a secondposition along a vertical axis of the body 30 (e.g., towards/away fromthe proximal cap 34), for example, by vertical movement caused by apushing device or user's fingers.

In some embodiments, the first and second prongs 64 a, 64 b areconfigured to flex such that tabs 68 a, 68 b, can be inserted throughthe first opening 42 into the internal cavity 48. When the first lockingfeatures 68 a, 68 b are aligned with the second locking features 38 a,38 b, the first and second prongs 64 a, 64 b return to an unflexedposition, positioning the first locking features 68 a, 68 b within thesecond locking features 38 a, 38 b and at least partially beneath thestop surface 80.

In some embodiments, a distal portion 72 b of each of the first lockingfeatures 68 a, 68 b are angled or curved to assist in insertion of thelocking insert 60 into the internal cavity 48. For example, in someembodiments, the distal portion 72 b defines a ramp configured to reducethe required flex distance (e.g., the distance that each of the firstlocking features 68 a, 68 b must travel towards a center line) forinsertion of the locking insert 60 and to transfer an insertion force tothe prongs 64 a, 64 b.

FIGS. 3A-3C illustrate the knotless button 14 a having the lockinginsert 60 positioned in a second position, in accordance with someembodiments. As shown in FIGS. 3A-3C, the locking insert 60 is fullyinserted into the internal cavity 48 in the second position such thatthe locking insert 60 extends through the strand receiving space 52.When the locking insert 60 is in the second position, the portion of theflexible strand 4 extending beneath the locking insert 60 is clamped orcompressed and the adjustable loop 6 is maintained at the preselectedlength.

As shown in FIG. 3C, in some embodiments, when the locking insert 60 ispositioned at a second position, the first locking elements 68 a, 68 b,are positioned within and/or interact with the second locking features38 a, 38 b defined by the body 30. The second locking features 38 a, 38b allow the prongs 64 a, 64 b of the locking insert 60 to return to anunflexed position. In some embodiments, a flat proximal side 72 a of thefirst locking features 68 a, 68 b interact with a stop surface 80defined by the body 30. The stop surface 80 prevents proximal movementof the locking insert 60 after insertion into the internal cavity 48.

In some embodiments, the body 30 of the knotless button 14 a defines aresiliently deformable material that is configured to be temporarilydeformed to release the locking insert 60 from the internal cavity 48.For example, in some embodiments, the body 30 can be squeezed orotherwise deformed to release the first locking features 68 a, 68 b fromthe second locking features 38 a, 38 b and allow the locking insert 60to be removed proximally from the internal cavity 48. In otherembodiments, temporary deformation of the body 30 can release firstlocking features 68 a. 68 b and second locking features 38 a. 38 b,reposition stop surfaces 80, and/or otherwise allow movement of thelocking insert 60 from the second position to the first position. Afterthe locking insert 60 is transitioned back to the first position, thebody 30 is returned to a pre-deformed shape and the locking insert 60can be reinserted into the internal cavity 48 to lock the adjustableloop 6 at a newly selected length.

FIG. 3 illustrates an anchoring construct 2 a including a knotlessbutton 14 b coupled to an adjustable loop 6, in accordance with someembodiments. The anchoring construct 2 a is similar to the anchoringconstruct 2 discussed in conjunction with FIG. 1 and the knotless button14 b is similar to the knotless button 14 a discussed in conjunctionwith FIGS. 2A-3C, and similar description is not repeated herein. Theanchoring construct 2 a includes a flexible strand 4 defining a firstadjustable loop 6. The first adjustable loop 6 is coupled to theknotless button 14 b. When the locking insert 60 is positioned in thefirst position, the adjustable loop 6 can be shortened and/or lengthenedto a preselected length. A first portion of the flexible strand 4defining the adjustable loop 6 passes through a loop passage 36 definedby the loop openings 36 a, 36 b in the body 30 and the loop opening 70in the locking insert 60. A second portion of the flexible strand 4passes through the strand receiving space 52 below the distal end 62 bof the locking insert 60. In some embodiments, an adjustment strand 12extends proximally from the body 30 and can be manipulated (e.g.,pulled) to shorten/lengthen the adjustable loop 6. When the adjustableloop 6 is adjusted to a preselected length, the locking insert 60 istransitioned to the second position with respect to the body 30.

In the second position, the locking insert 60 locks the flexible strand4 between the locking insert 60 and the body 30 to maintain theadjustable loop 6 at a preselected length. For example, in someembodiments, the flexible strand 4 is looped through the first andsecond loop openings 36 a, 36 b and beneath the distal end 62 b of thelocking insert 48 such that a portion of the flexible strand 4 ispositioned within strand receiving space 52. In other embodiments,additional loop openings (not shown) can be defined by the body 30distally of the first and second loop openings 36 a, 36 b and theflexible strand 4 can be looped through the additional openings todefine an adjustable loop 6. In some embodiments, an adjustment portion12 of the adjustable loop 6 extends proximally through the proximal cap32 of the knotless button 14 b. In some embodiments, the adjustmentportion 12 extends through a first adjustment hole 40 a defined by theproximal cap 34. The adjustment portion 12 is configured to adjust thelength of the adjustable loop 6. For example, in some embodiments,proximal movement of the adjustment portion 12 shortens the length(e.g., diameter) of the adjustable loop 6 and distal movement of theadjustment portion 12 lengthens the adjustable loop 6.

FIG. 5 illustrates an anchoring construct 2 b including the knotlessbutton 14 b coupled to first and second adjustable loops 6 a, 6 b, inaccordance with some embodiments. The anchoring construct 2 b is similarto the anchoring construct 2 a discussed in conjunction with FIG. 4, andsimilar description is not repeated herein. The flexible strand 4 islooped multiple times through the loop passage 36 and beneath theproximal end 62 b of the locking insert 60 to define the first andsecond adjustable loops 6 a, 6 b. A first adjustment portion 12 aextends proximally through a first adjustment hole 40 a and a secondadjustment portion 12 b extends proximally through a second adjustmenthole 40 b. The first adjustment portion 12 a is configured to adjust thelength of the first adjustable loop 6 a and the second adjustmentportion 12 b is configured to adjust the length of the second adjustableloop 6 b. Although embodiments are illustrated with one or twoadjustable loops, those skilled in the art will recognize that theknotless button 14 b can be coupled to any number of adjustable loopsdefined by one or more flexible strands.

FIGS. 6A-6E illustrate a knotless button 14 c, in accordance with someembodiments. The knotless button 14 c is similar to the knotless button14 a discussed above, and similar description is not repeated herein.The knotless button 14 c includes a body 30 a having a tapered portion50 at a distal end 32 b. The tapered portion 50 tapers from the firstdiameter 37 a of the body 30 a to a third diameter 37 c defined by thedistal end 32 b. The tapered portion 50 begins distally of the one ormore loop openings 34 a, 34 b. In some embodiments, the internal cavity48 maintains a constant width through the tapered portion 50 and onlythe outer surface of the body 30 a is tapered. In other embodiments, theinternal cavity 48 tapers in conjunction with the tapered portion 50 todefine a tapered internal cavity.

In some embodiments, the proximal cap 34 b includes a plurality ofadjustment openings 40 a, 40 b. The plurality of adjustment openings 40a, 40 b are sized and configured to receive a portion of an adjustmentstrand 12 therethrough (see FIG. 3). In some embodiments, a firstadjustment opening 40 a and a second adjustment opening 40 b aresymmetrically positioned about the insert opening 42. In otherembodiments, the adjustment openings 40 a, 40 b can be non-symmetricallyarranged. Although embodiments are illustrated with two adjustmentopenings 40 a, 40 b, it will be appreciated that the knotless button 14c can include any suitable number of adjustment openings 40 a, 40 b eachconfigured to receive one or more adjustment portions 12 therethrough.

FIGS. 7A-7D illustrate a knotless button 14 d, in accordance with someembodiments. The knotless button 14 d is similar to the knotless button14 c discussed in conjunction with FIGS. 6A-6E, and similar descriptionis not repeated herein. The knotless button 14 d includes a proximal cap34 c having a plurality of adjustment slots 84 a, 84 b instead ofadjustment openings 40 a, 40 b. The adjustment slots 84 a, 84 b aresized and configured to receive a portion of an adjustment strand 12therethrough. The adjustment slots 84 a, 84 b extend longitudinally toallow the adjustment strand 12 to be conveniently positioned duringinsertion and anchoring of the knotless button 14 d.

FIG. 8 illustrates a locking insert 60 a, in accordance with someembodiments. The locking insert 60 a is similar to the locking insert 60discussed in conjunction with FIGS. 4A-5C, and similar description isnot repeated herein. The locking insert 60 a includes a circular loopopening 70. The circular loop opening 70 is sized and configured toreceive a flexible strand 4 defining at least one adjustable loop 6therethrough. In some embodiments, the locking insert 60 a includes aslot 66 configured to allow the first prong 64 a and the second prong 64b to flex towards a center line of the locking insert 60 a, as discussedabove.

FIG. 9 illustrates an anchoring construct 2 d coupled to a needle andconfigured for insertion through a bone tunnel, in accordance with someembodiments. The anchoring construct 2 d includes a knotless button 14 ecoupled to a plurality of adjustable loops 6 a-6 b at a proximal end 8.The distal end 10 of the adjustable loops 6 a-6 b are coupled to a flatbutton 16. The flat button 16 is further coupled to a needle 86 by aplurality of pull strands 88. The needle 86 is sized and configured forinsertion through a bone tunnel 106 defined through at least one bone102, 104. In some embodiments, the flat button 16 is omitted and thepull strands 88 are coupled directly to the adjustable loops 6 a, 6 b.

FIG. 10 illustrates an anchoring construct 2 e partially coupled to afirst bone 102 and a second bone 104 through a bone plate 20, inaccordance with some embodiments. The anchoring construct 2 e is similarto the anchoring construct 2 d discussed in conjunction with FIG. 9, andsimilar description is not repeated herein. The needle 86 is insertedthrough a bone tunnel (see FIG. 1) defined by the first and second bones102, 104. In some embodiments, the needle 86 is inserted into the bonetunnel through a button opening formed in the bone plate 20 (see FIGS.11A-11C). In some embodiments, the bone plate 20 is coupled to the firstbone 102 prior to insertion of the needle 86 through the bone tunnel.For example, in the illustrated embodiment, the bone plate 20 is coupledto the first bone 102 by a plurality of fasteners inserted throughfastener holes defined by the bone plate. In other embodiments, the boneplate 20 is coupled to the bone by insertion and tightening of theanchoring construct 2 e.

FIGS. 11A-11C illustrates a first knotless button 14 f and a secondknotless button 14 g inserted through a button hole in a bone plate 20a, in accordance with some embodiments. Each of the knotless buttons 14f, 14 g are inserted through button holes 28 extending from an outersurface 26 of the plate 20 a to an inner surface 24 (or bone contactsurface). In some embodiments, each of the button holes 28 define acountersink 82 (see FIG. 11B) such that the proximal end of the knotlessbuttons 14 f, 14 g are flush with the outer surface 26 when fullyinserted into the button holes 28. In other embodiments, the knotlessbuttons 14 f, 14 g can extend at least partially above the outer surface26. The bone plate 20 a further defines a plurality of fastener holes 29sized and configured for receiving a variable angle fastener therein.One or more variable angle fasteners can be used to anchor the boneplate 20 a to a first bone (or bone fragment) prior to and/or afterinsertion of the knotless buttons 14 f, 14 g through the button holes28. In some embodiments, the fastener holes 29 define at least a partialthread 31 configured to allow variable angle insertion of a fastener.

As shown in FIG. 11B, the knotless buttons 14 f, 14 g are insertedthrough the button holes 28 fully assembled (e.g., with the lockinginserts 60 preinserted). As discussed above, one or more adjustableloops defined by a flexible strand can be tightened fix a position of afirst bone (or bone fragment) and a second bone (or bone fragment). Insome embodiments, tightening of the adjustable loops tightens theknotless buttons 14 f, 14 g against the bone plate 20 a and temporarilyanchors the plate 20 a to a first bone.

FIG. 11C shows a cross-section of the bone plate 20 a having the firstknotless button 14 f inserted into a first button hole 28. The firstknotless button 14 f can be inserted on an axis 99 a that isperpendicular to the axis of curvature 99 b of the bone plate 20 aand/or can be inserted at an angle with respect to the axis of curvature99 b. In some embodiments, the axis 99 a of the first knotless button 14f can intersect with an axis of a fastener hole 29. In such embodiments,a fastener is not inserted through the fastener hole 29.

FIG. 12 illustrates a flat button 16 a, in accordance with someembodiments. The flat button 16 a includes a first side 90 a and asecond side 90 b coupled by a center post 92. Each of the first side 90a and the second side 90 b include a first arm 94 a and a second arm 94b extending at a predetermined arc from the center post 92. Each of thearms 94 a, 94 b are sized and configured to receive a portion of anadjustable loop 6 thereabout. The flat button 16 a is configured tocouple a distal end of an adjustable loop 6 to a second bone 104.

In some embodiments, the flat button 16 a is sized and configured to beinserted through a bone tunnel 106 in a first configuration and toanchor a distal end of an adjustable loop 6 to a second bone in a secondconfiguration. For example, in some embodiments, the flat button 16 ahas a first diameter along a first axis 96 less than a diameter of thebone tunnel 106. When the flat button 16 a is oriented lengthwise withthe first diameter perpendicular to the longitudinal axis of the bonetunnel 106, the flat button 16 a can be inserted through the bone tunnel106. After insertion, the flat button 16 a is oriented such that a flatsurface of the flat button 16 a is positioned against the second bone104 to anchor a second end of an adjustable loop 6. In otherembodiments, the flat button 16 a is coupled to the second end of theadjustable loop 6 after the adjustable loop 6 is inserted through thebone tunnel 106. In some embodiments, the flat button 16 a defines aplurality of holes 98 sized and configured to receive an adjustable loop6 and/or flexible strand 4 therethrough.

FIG. 13 illustrates a method 200 of syndesmosis repair using ananchoring construct 2 as described herein, in accordance with someembodiments. At step 202, a bone tunnel 106 is formed through a firstbone 102 and a second bone 104. The bone tunnel 106 can be formed usingany suitable device, such as, for example, a drill, a k-wire, a needle,etc. In some embodiments, step 202 is performed simultaneously with onemore later steps, such as step 206 discussed below.

At optional step 204, a bone plate 20 is coupled to the first bone 102.The bone plate 20 includes one or more knot capsule openings, and one ormore fastener holes 74 a-74 d. The bone plate 20 can be coupled to thefirst bone 102 using one or more fasteners 76 inserted through one ormore of the fastener holes 74 a-74 d. In other embodiments, the boneplate 20 can be temporarily coupled to the first bone 102 by, forexample, a k-wire or other temporary fixation device.

At step 206, an anchor construct 2 is coupled to the first bone 102 andthe second bone 104. The anchor construct 2 is coupled to the first andsecond bones 102, 104 by inserting a flexible strand 4 defining at leastone adjustable loop 6 through the bone tunnel 106. In some embodiments,a distal end 10 of the adjustable loop 6 is coupled to a flat button 16.The flat button 16 can be coupled to the distal end 10 of the adjustableloop 6 prior to insertion of the adjustable loop 6 through the bonetunnel 106. In such embodiments, the flat button 16 is sized andconfigured for insertion through the bone tunnel 106 in at least a firstconfiguration and is sized and configured to prevent movement throughthe bone tunnel 106 in a second configuration. In some embodiments, theflat button 16 is coupled to the distal end 10 of the adjustable loop 6after insertion of the adjustable loop 6 through the bone tunnel 106.

At step 208, the distal end 10 of the adjustable loop 6 is coupled tothe second bone. For example, in some embodiments, the flat button 16 iscoupled to the adjustable loop 6 and positioned against an outer edge ofthe second bone 104.

At step 210, the adjustable loop 6 is shortened to reduce the distancebetween the first bone 102 and the second bone 104 to a predeterminedspacing. The adjustable loop 6 can be shortened by, for example, anadjustment portion 12 extending through a first opening 42 formed in aproximal cap 34 a of a knotless button 14. Applying a proximal force tothe adjustment portion 12 shortens the adjustable loop 6. It will beappreciated that additional methods can be used to shorten theadjustable loop 6, such as, for example, pulling the proximal end 8 ofthe adjustable loop 6 through one or more openings of the knot capsule14 and manually adjusting the length of the adjustable loop 6.

At step 212, a locking insert 60 positioned within an internal cavity 48defined by the knotless button 14 is transitioned from a first positionto a second position to lock the adjustable loop 6 at the selectedlength. In some embodiments, the locking insert 60 automaticallytransitions from the first position to the second position when theadjustable loop 6 is shortened to a predetermined length.

At optional step 214, a proximal force can be applied to the lockinginsert 60 by a release loop 54 to transition the locking insert 60 fromthe second position to the first position. The method can optionallyreturn to step 210 to further adjust the length of the adjustable loop6. The method 200 then returns to step 212 to lock the locking insert 60when the adjustable loop 6 is adjusted to a second predetermined length.

In various embodiments, a knotless button includes a body defining aproximal portion and a distal portion. The body further defines aninternal cavity and a first loop opening extending from the internalcavity to an outer surface of the body. A locking insert is slideablypositioned within the internal cavity. The locking insert defines asecond loop opening extending from a first side of the locking insert toa second side of the locking insert. The locking insert is slideablymoveable from a first position to a second position within the internalcavity. A flexible strand defines a first adjustable loop extendingthrough the first loop opening and the second loop opening. The lockinginsert is slideably moveable from a first position configured to allowadjustment of the first adjustable loop to a second position configuredto lock the first adjustable loop.

In some embodiments, the flexible strand extends from a first side ofthe locking insert to a second side of the locking insert through thesecond loop opening, from the second side of the locking insert to thefirst side of the locking insert beneath a distal edge of the lockinginsert, and from the first side of the locking insert to the second sideof the locking insert through the second suture opening. In someembodiments, the first adjustable loop is configured to apply a force tothe locking insert. The force applied by the first adjustable looptransitions the locking insert from the first position to the secondposition.

In some embodiments, the locking cavity defines at least one firstlocking feature and the locking insert comprises at least one secondlocking feature. The first locking feature is configured to interfacewith the second locking feature to maintain the locking insert in afixed position with respect to the body. The at least one first lockingfeature can be a slot and the at least one second locking feature can bea tab.

In some embodiments, the body is tapered at a distal end portion. Thebody can further defines a second suture opening extending from theinternal cavity to the outer surface of the body. The distal portion ofthe body is sized and configured to be received within a bone tunnel.

In some embodiments, a knotless button includes a body having a proximalportion and a distal portion. The body defines an internal cavityincluding at least one first locking feature. A locking insert isslideably positioned within the internal cavity. The locking insertdefines a first loop opening extending from a first side to a secondside. The locking insert is slideably moveable from a first position toa second position and is configured to receive a flexible stranddefining a first adjustable loop through the first loop opening. Thelocking insert includes at least one second locking feature configuredto selectively couple to the first locking feature to prevent movementof the locking insert with respect to the body.

In some embodiments, the first loop extends from a first side of thelocking insert to a second side of the locking insert through the firstloop opening, from the second side of the locking insert to the firstside of the locking insert beneath a distal edge of the locking insert,and from the first side of the locking insert to the second side of thelocking insert through the first suture opening. The adjustable loop canapply a predetermined force to the locking insert when the adjustableloop has a predetermined length. The force applied by the adjustableloop transitions the locking insert from the first position to thesecond position.

In some embodiments, the at least one first locking feature is a slotand the at least one second locking feature is a tab. The body can betapered at the distal portion. The distal portion of the body is sizedand configured to be received within a bone tunnel.

In some embodiments, a release strand is coupled to the locking insert.The release strand extends proximally from the locking insert and isconfigured to selectively release the at least one first locking featureand the at least one second locking feature.

In some embodiments, a method of coupling a first bone and a second boneis disclosed. The method includes forming a bone tunnel through a firstbone and a second bone. A knotless button is inserted at least partiallythrough the bone tunnel. The knotless button includes a body having aproximal portion and a distal portion and further defining an internalcavity and a first loop opening, a locking insert slideably positionedwithin the internal cavity and defining a second loop opening extendingfrom a first side to a second side, and a flexible strand defining afirst adjustable loop extending through the first loop opening and thesecond loop opening. The first adjustable loop is coupled to the secondbone and is adjusted to position the first bone and the second bone.Adjusting the first adjustable loop slideably transitions the lockinginsert from a first position in which the first adjustable loop isadjustable to a second position in which the first adjustable loop islocked.

In some embodiments, the method further includes locking the lockinginsert with respect to the body. The internal cavity defines at leastone first locking feature and the locking insert defines at least onesecond locking feature. The locking insert is locked by coupling the atleast one first locking feature and the at least one second lockingfeature.

In some embodiments, the method further includes uncoupling the at leastone first locking feature and the at least one second locking feature totransition the locking insert from the second position to the firstposition. The at least one first locking feature and the at least onesecond locking feature are released by a proximal force applied by arelease loop coupled to the locking insert. The first adjustable loop isadjusted and locking insert is transitioned from the first position tothe second position.

In some embodiments, the knotless button is inserted through a holedefined in a bone plate prior to inserting the knotless button into thebone tunnel. The bone plate defines a body having an outer surface and abone contact surface. The bone plate is maintained in a fixed positionwith respect to the first bone.

In some embodiments, coupling the first adjustable loop to the secondbone comprises coupling a flat button to the second bone. The flatbutton is coupled to a distal end of the first adjustable loop andincludes at least one dimension greater than a diameter of the bonetunnel.

Although the subject matter has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodiments,which may be made by those skilled in the art.

1-22. (canceled)
 23. A knotless button, comprising: a body defining aproximal portion, a distal portion, and an internal cavity, wherein theinternal cavity includes at least one first locking feature; a lockinginsert slideably receivable within the internal cavity, the lockinginsert defining a first loop opening extending from a first side to asecond side, wherein the locking insert is slideably moveable from afirst position to a second position within the internal cavity, whereinthe locking insert is configured to receive a flexible strand defining afirst adjustable loop through the first loop opening, wherein thelocking insert includes at least one second locking feature, and whereinthe at least one first locking feature and the at least one secondlocking feature are configured to selectively couple to prevent movementof the locking insert with respect to the body.
 24. The knotless buttonof claim 23, wherein the first loop extends from a first side of thelocking insert to a second side of the locking insert through the firstloop opening, from the second side of the locking insert to the firstside of the locking insert beneath a distal edge of the locking insert,and from the first side of the locking insert to the second side of thelocking insert through the first suture opening.
 25. The knotless buttonof claim 24, wherein the adjustable loop applies a predetermined forceto the locking insert when the adjustable loop has a predeterminedlength.
 26. The knotless button of claim 25, wherein the force appliedby the adjustable loop transitions the locking insert from the firstposition to the second position.
 27. The knotless button of claim 23,wherein the at least one first locking feature is a slot and the atleast one second locking feature is a tab.
 28. The knotless button ofclaim 23, wherein the body is tapered at the distal portion.
 29. Theknotless button of claim 23, wherein the distal portion of the body issized and configured to be received within a bone tunnel.
 30. Theknotless button of claim 23, comprising a release strand coupled to thelocking insert, wherein the release strand extends proximally from thelocking insert, and wherein the release strand is configured toselectively release the at least one first locking feature and the atleast one second locking feature.
 31. A knotless button, comprising: abody defining a proximal portion, a distal portion, and an internalcavity communicating with a first loop opening located on an outersurface of the body; a locking insert moveably positioned within theinternal cavity, the locking insert defining a second loop openingextending from a first side of the locking insert to a second side ofthe locking insert, and wherein the locking insert is moveable from afirst position to a second position within the internal cavity; and aflexible strand defining a first adjustable loop extending through thefirst loop opening and the second loop opening so as to be arranged toapply a force to the locking insert so that the locking insert movesfrom a first position configured to allow adjustment of the firstadjustable loop to a second position configured to lock the firstadjustable loop.
 32. The knotless button of claim 31, wherein theflexible strand extends from a first side of the locking insert to asecond side of the locking insert through the second loop opening andfrom the second side of the locking insert to the first side of thelocking insert beneath a distal edge of the locking insert.
 33. Theknotless button of claim 31, wherein the locking insert defines at leastone locking tab and the body defines a slot that communicates with theinternal cavity, wherein the tab is configured to interface with theslot to maintain the locking insert in a fixed position with respect tothe body.
 34. The knotless button of claim 31, wherein the body istapered at a distal end portion.
 35. The knotless button of claim 31,wherein the body further defines a second suture opening communicatingwith the internal cavity of the body.
 36. A method for coupling a firstbone and a second bone, comprising: forming a bone tunnel through afirst bone and a second bone; inserting a knotless button at leastpartially through the bone tunnel, the knotless button comprising a bodydefining a proximal portion, a distal portion, and an internal cavitycommunicating with a first loop opening, a locking insert moveablypositioned within the internal cavity, the locking insert defining asecond loop opening extending from a first side of the locking insert toa second side, and wherein the locking insert is moveable from a firstposition to a second position within the internal cavity, and a flexiblestrand defining a first adjustable loop extending through the first loopopening and the second loop opening; coupling the first adjustable loopto the second bone; and adjusting the first adjustable loop to positionthe first bone and the second bone, wherein adjusting the firstadjustable loop moves the locking insert from a first position in whichthe first adjustable loop is adjustable to a second position in whichthe first adjustable loop is locked.
 37. The method of claim 36,comprising locking the locking insert with respect to the body, whereinthe locking insert defines at least one locking tab and the body definesa slot that communicates with the internal cavity, wherein the tab isconfigured to interface with the slot to maintain the locking insert ina fixed position with respect to the body.
 38. The method of claim 37,comprising: uncoupling the tab from the slot to transition the lockinginsert from the second position to the first position, wherein the tabis released from the slot in the body by a proximal force applied by arelease loop coupled to the locking insert; adjusting the firstadjustable loop; and transitioning the locking insert from the firstposition to the second position.
 39. The method of claim 36, comprisinginserting the knotless button through a hole defined in a bone plateprior to inserting the knotless button into the bone tunnel, wherein thebone plate defines a body having an outer surface and a bone contactsurface, and wherein the bone plate is maintained in a fixed positionwith respect to the first bone.
 40. The method of claim 36, whereincoupling the first adjustable loop to the second bone comprises couplinga flat button to the second bone, wherein the flat button is coupled toa distal end of the first adjustable loop, and wherein the flat buttonincludes at least one dimension greater than a diameter of the bonetunnel.